Jon D. Duke MD, MS
OHDSI Annual Symposium
October 20
th
, 2015
Translation of Open-Source Analytics
into Patient-Centered Care
Funding Disclosures
• Funding from Bayer, Janssen, Lilly, Merck
– Research
– Consulting
– Coming up with great drug names (Zaxyrbeard)
We’ve Arrived!
© Universal Studios. All rights Reserved
© Universal Studios. All rights Reserved
© Universal Studios. All rights Reserved
© Universal Studios. All rights Reserved
© Universal Studios. All rights Reserved
The ‘Bedside’ of
Drug Safety Informatics
Communication of new and
established drug safety evidence to
improve patient care
Adverse Reactions
• Nausea
• Vomiting
• Headache
• Dizziness
• Rash
• Pruritis
• Diarrhea
• Urticaria
• Fever
Post-Marketing Events
• Angioedema
• Stevens-Johnson
• Hypersensitivity
• Thrombocytopenia
• Anaphylactic reaction
• TEN
• Erythema multiforme
• Hepatitis
• Urticaria
(76%)
(69%)
(66%)
(63%)
(60%)
(59%)
(57%)
(51%)
(46%)
(29%)
(24%)
(47%)
(42%)
(28%)
(21%)
(22%)
(26%)
(51%)
Common Things Being Common
70
103
111
118
121
127
165
185
227
241
384
0 50 100 150 200 250 300 350 400
All Drugs
Bisphosphonates
Beta Blockers
Benzodiazepines
NSAIDs
Statins
ACE-Inhibitors
Proton Pump Inhibitors
5-HT1 Agonists (Triptans)
Atypical Antipsychotics
SSRI's
Mean Number of ADE's per label
Drug Class
ADEs per Label for 10 Common Drug Classes
70
103
111
118
121
127
165
185
227
241
384
0 50 100 150 200 250 300 350 400
All Drugs
Bisphosphonates
Beta Blockers
Benzodiazepines
NSAIDs
Statins
ACE-Inhibitors
Proton Pump Inhibitors
5-HT1 Agonists (Triptans)
Atypical Antipsychotics
SSRI's
Mean Number of ADE's per label
Drug Class
ADEs per Label for 10 Common Drug Classes
0
100
200
300
400
500
600
1930 1940 1950 1960 1970 1980 1990 2000 2010 2020
Labeled Adverse Reactions by Year of Approval
Labeled ADE's
Enter PENELOPE
Personalized
Exploratory
Navigation &
Evaluation
Of
Labels for
Product
Effects
PENELOPE
• PENELOPE leverages OHDSI’s evidence
generation and curation tools to provide
context to safety information on drug labels
• The nature of this context may differ for
different stakeholders (e.g., providers,
researchers, patients)
A Big Supporting Cast
ACHILLES:
Database
profiling
CIRCE:
Cohort
definition
HERACLES:
Cohort
characterization
HERMES:
Vocabulary
exploration
LAERTES:
Drug-AE
evidence base
HOMER:
Population-level
causality
assessment
PLATO:
Patient-level
predictive
modeling
LAERTES
Drugs (RxNorm)
Conditions
(SNOMED)
Spontaneous adverse
event data
(FAERS, VigiBaseâ„¢,
ClinicalTrials.gov)
MedDRA
-> SNOMED
Freetext,
ATC
-> RxNorm
Literature
(PubMed, SemMed)
MeSH, UMLS
-> SNOMED
MeSH,
UMLS
-> RxNorm
Product labeling
(SPL, SPC)
Freetext ->
MedDRA®
-> SNOMED
SPL Set ID
-> RxNorm
Indications /
Contraindications
(FDBâ„¢)
ICD-9-CM
-> SNOMED
NDC/GenSeq
Num
-> RxNorm
Observational
healthcare data
(claims + EHR)
ICD-9-CM,
ICD-10
-> SNOMED
NDC/GPI/ATC
-> RxNorm
Drug
classifications
(ATC, NDF-RT)
Condition
classifications
(MedDRA®,
Ontology of
Adverse Events)
Source to Drug
Mapping
Source to HOI
Mapping
Evidence
Sources
Shall We Take a Look?
PENELOPE - it takes a community!
Anthony Sena
Janssen
Erica Voss
Janssen
Matt Levine
Columbia
Frank DeFalco
Janssen
Hamed Abedtash
Indiana U
Lee Evans
LTC Consulting
Rich Boyce
UPitt
Wen Zhang
UPitt
Patrick Ryan
Janssen
Join the journey
Interested in OHDSI?
Questions or comments?
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